Gut microbiome links to outcomes in intracranial arterial stenosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

GROW-ICAS is a prospective observational cohort that enrolls adults aged 30-80 with intracranial arterial stenosis confirmed by CTA, MRA, or DSA. The study collects stool for gut microbiota analysis and blood for metabolomic and transcriptomic profiling alongside standardized imaging and clinical assessments. Investigators will correlate microbial and molecular profiles with functional outcomes, intracranial plaque imaging characteristics, and post-stroke non-motor dysfunctions such as cognitive impairment, depression, anxiety, and fatigue. Key exclusions (non-atherosclerotic causes, recent interventions, active hemorrhage, major comorbidities, or inability to follow up) are applied to maintain a homogeneous cohort.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 30-80 years.
2. Intracranial arterial stenosis confirmed by CTA/MRA/DSA.
3. Local residency ≥6 consecutive months.
4. Signed informed consent.

Exclusion Criteria:

1. Tandem extracranial stenosis (≥50%) proximal to the target intracranial stenotic vessel.
2. Non-atherosclerotic intracranial stenosis.
3. Extracranial/intracranial endovascular treatment within 30 days pre-enrollment or planned intervention within 6 months.
4. Intracranial hemorrhage within 90 days pre-enrollment.
5. Pre-existing intracranial tumor, cerebral aneurysm, or arteriovenous malformation.
6. Cardioembolic embolism.
7. Active bleeding/hemorrhagic diathesis.
8. Major surgery within 30 days pre-enrollment or planned within 6 months post-enrollment.
9. Severe neurological deficits impairing independent living or dementia/psychiatric disorders hindering follow-up.
10. Pregnancy/lactation/planned pregnancy.
11. Chronic inflammatory/autoimmune diseases.
12. Uncontrolled hypertension or diabetes.
13. Severe cardiac/hepatic/renal dysfunction, hematologic disorders, malignancy, or life expectancy \<1 year.
14. MRI contraindications.
15. History of depression/anxiety/cognitive impairment requiring therapy.
16. Antibiotic/probiotic/glucocorticoid/immunosuppressant use within 1 month pre-enrollment.
17. Current/planned participation in other trials.
18. Inability to cooperate due to psychiatric/emotional disorders.
19. Other investigator-deemed ineligibility.

Where it's running

• Nanjing First Hospital, Nanjing Medical University
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Junshan Zhou
• Email: zhjsh333@126.com
• Phone: 8602587726218

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• PCSK9 inhibitor plus statin for reversing asymptomatic intracranial artery plaque

  This trial will test whether adding a PCSK9 inhibitor to statin therapy can shrink plaque and improve narrowing in adults aged 18–60 with asymptomatic intracranial artery stenosis (≥50%).

  Recruiting at 2 sites Phase 4 Peking Union Medical College Hospital · Beijing, Beijing Municipality and 18 other locations · NCT06902740

• Evaluating a new drug-eluting stent for treating intracranial artery stenosis in China

  This study is testing a new type of stent to see if it can safely help people in China with narrowing arteries in the brain and reduce their risk of stroke or death.

  Recruiting at 5 sites Sino Medical Sciences Technology Inc. · Chenzhou and 4 other locations · NCT05692882

• Improving blood lipid management for patients with symptomatic intracranial artery stenosis

  This study is testing whether adding a new type of cholesterol-lowering medication to standard treatment can help people with narrowed brain arteries reduce their chances of having another stroke.

  Recruiting at 2 sites Nanjing First Hospital, Nanjing Medical University · Nanjing, Jiangsu and 1 other locations · NCT05397405

• Tirofiban treatment for patients with high-risk cerebrovascular events

  This study is testing whether the drug tirofiban can help prevent new strokes in people aged 40 and older who have had serious but non-disabling cerebrovascular events.

  Recruiting at 5 sites Phase 3 Beijing Tiantan Hospital · Harbin, Heilongjiang and 4 other locations · NCT06319846

• Imaging of atherosclerotic plaques in arteries using advanced MRI techniques

  This study is testing a new MRI technique to see if it can give better pictures of artery plaques in people with moderate to severe narrowing of the arteries, helping to understand their risk for stroke.

  Recruiting Shanghai Jiao Tong University Affiliated Sixth People's Hospital · Shanghai · NCT06754956

• Comparing blood-thinning therapies for patients with severe intracranial artery narrowing

  This study is testing how well different blood-thinning medications work for stroke patients with severe narrowing of the arteries in the brain, using MRI scans to find out who might not be responding to treatment.

  Recruiting at 14 sites Yale University · Birmingham, Alabama and 27 other locations · NCT05907629

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.